← Product Code FRO · K243001
# Sterile Water USP and Sterile 0.9% Normal Saline USP (K243001)
_Laboratorios Biogalenic S.A. DE C.V. · FRO · Mar 6, 2025 · SU · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K243001
## Device Facts
- **Applicant:** Laboratorios Biogalenic S.A. DE C.V.
- **Product Code:** FRO
- **Decision Date:** Mar 6, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic
## Intended Use
For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding, and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.
## Device Story
Device consists of sterile, preservative-free aqueous solutions (Sterile Water USP or 0.9% Normal Saline USP) in polypropylene bottles. Used for external irrigation, wound debridement, and moistening dressings. Operated by clinicians or patients (OTC) via mechanical application of fluid to wound or device surfaces. Output is the physical irrigation/moistening of the target site. Benefits include facilitating wound cleaning and debridement through mechanical fluid action. Not for injection.
## Clinical Evidence
No clinical data. Evidence consists of biocompatibility testing per ISO 10993 (cytotoxicity, intracutaneous reactivity, sensitization, systemic toxicity, pyrogenicity), packaging/transportation validation (ASTM standards), and bench testing confirming compliance with USP monographs for sterility, endotoxins, pH, and chemical identification.
## Technological Characteristics
Aqueous solutions (Sterile Water or 0.9% NaCl) in polypropylene (PP) bottles with PP/PET aluminum induction seals. Mechanical irrigation principle. Terminal steam sterilization. Shelf life: 2 years. Complies with USP monographs for Water for Injection and Sodium Chloride for injection.
## Predicate Devices
- Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP ([K173276](/device/K173276.md))
## Submission Summary (Full Text)
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March 6, 2025
Laboratorios Biogalenic S.A. DE C.V. % Manoj Zacharias US Agent Liberty Management Group Ltd. 75 Executive Dr. Suite 114 Aurora, Illinois 60504
Re: K243001
Trade/Device Name: Sterile Water USP and Sterile 0.9% Normal Saline USP Regulatory Class: Unclassified Product Code: FRO Dated: February 7, 2025 Received: February 7, 2025
Dear Manoj Zacharias:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Mustafa A. Mazher -5
For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K243001
Device Name
Sterile Water USP and Sterile 0.9% Normal Saline USP
# Indications for Use (Describe)
Over-the-Counter Use:
For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin.
Prescription Use:
For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) SUMMARY
[AS REQUIRED BY 21 CFR 807.92]
#### I. SUBMITTER
| 510(k) Owner's Name | : | LABORATORIOS BIOGALENIC, S.A. DE C.V. | | |
|--------------------------|---|--------------------------------------------------------------------------------------|--|--|
| Address | : | Calle Claper, Blvd. Del Ejercito Nacional km 5.5
Soyapango, San Salvador, 1639 SV | | |
| Telephone | : | +503-2227-4133 | | |
| Fax | : | +503-2227-4466 | | |
| Contact person | : | Roberto Quiñonez | | |
| Designation | : | Plant Director | | |
| Contact Number | : | +503-2227-4133 EXT 106 | | |
| Contact Email | : | r.q@biogalenic.com.sv, biogal@biogalenic.com.sv | | |
| Date of Summary Prepared | : | 28.02.2025 | | |
# II. DEVICE
| Trade Name | : | Sterile Water USP and Sterile 0.9% Normal Saline USP |
|----------------------------|---|------------------------------------------------------|
| Device Common Name | : | Sterile Water USP and Sterile 0.9% Normal Saline USP |
| Device Classification Name | : | Dressing, Wound, Drug |
| Device Classification | : | Unclassified |
| Classification Panel | : | General and Plastic Surgery |
| Product Code | : | FRO |
# III. PREDICATE DEVICE
| Predicate Device Name | : | Medline Sterile Water USP and Medline Sterile 0.9% Normal
Saline USP |
|-----------------------|---|-------------------------------------------------------------------------|
| 510(k) Number | : | K173276 |
| Device Classification | : | Unclassified |
| Product Code | : | FRO |
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#### DEVICE DESCRIPTION IV.
The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal.
These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.
| Laboratorios Biogalenic | Description |
|-------------------------|------------------------------------------------------------|
| Item Number | |
| 78718-00060 | 100 mL Sterile Water, USP (OTC) |
| 78718-00061 | 250 mL Sterile Water, USP (OTC) |
| 78718-00062 | 500 mL Sterile Water, USP (OTC) |
| 78718-00063 | 1000 mL Sterile Water, USP (OTC) |
| 78718-00047 | 100 mL Sterile Water, USP (Prescription Use) |
| 78718-00048 | 250 mL Sterile Water, USP (Prescription Use) |
| 78718-00049 | 500 mL Sterile Water, USP (Prescription Use) |
| 78718-00050 | 1000 mL Sterile Water, USP (Prescription Use) |
| 78718-00065 | 100 mL Sterile 0.9% Normal Saline, USP (OTC) |
| 78718-00066 | 250 mL Sterile 0.9% Normal Saline, USP (OTC) |
| 78718-00067 | 500 mL Sterile 0.9% Normal Saline, USP (OTC) |
| 78718-00068 | 1000 mL Sterile 0.9% Normal Saline, USP (OTC) |
| 78718-00052 | 100 mL Sterile 0.9% Normal Saline, USP (Prescription Use) |
| 78718-00053 | 250 mL Sterile 0.9% Normal Saline, USP (Prescription Use) |
| 78718-00054 | 500 mL Sterile 0.9% Normal Saline, USP (Prescription Use) |
| 78718-00055 | 1000 mL Sterile 0.9% Normal Saline, USP (Prescription Use) |
Laboratorios Biogalenic Sterile Water USP and Sterile 0.9% Normal Saline USP are available in the following configurations:
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#### V. INDICATIONS FOR USE
## For Over-the-Counter Use:
For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin.
# For Prescription Use:
For moistening absorbent wound dressings and for moistening, and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.
#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS VI.
The Sterile Water USP, and Sterile 0.9% Normal Saline USP medical device contains a colorless, transparent solution without any preservatives or antimicrobial agents added. It is used only for external irrigation and wound debridement, not for injection purposes and it is a single use device. The solution's chemical composition is either sterile saline (0.9% sodium chloride) which comply with their respective USP Monograph standards. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservativefree, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal.
# VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Features
compared | Proposed Device | Predicate Device | Result |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Name | Sterile Water USP and Sterile
0.9% Normal Saline USP | Medline Sterile Water USP and
Medline Sterile 0.9% Normal
Saline USP | NA |
| 510(k)
Number | K243001 | K173276 | NA |
| Manufacturer | LABORATORIOS BIOGALENIC,
S.A. DE C.V. | Medline Industries, Inc. | NA |
| Classification | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | Same |
| Prescription
Use or OTC
Use | Both | Both | Same |
| Contact
duration | <24 hours | <24 hours | Same |
| Features
compared | Proposed Device | Predicate Device | Result |
| Single-Use
Vs. Reusable | Single use | Single use | Same |
| Indication
For Use | Over-the-Counter Use:
For moistening absorbent wound
dressings and cleaning minor
cuts, minor burns, superficial
abrasions, and minor irritations
of the skin.
Prescription Use:
For moistening absorbent wound
dressings and for moistening,
debriding, and cleaning acute
and chronic dermal lesions, such
as Stage I-IV pressure ulcers,
stasis ulcers, diabetic ulcers, foot
ulcers, post-surgical wounds,
first and second-degree burns,
cuts, abrasions, and minor skin
irritations and for device
irrigation. | Over-the-Counter Use:
For moistening absorbent
wound dressings and cleaning
minor cuts, minor burns,
superficial abrasions, and minor
irritations of the skin.
Prescription Use:
For moistening absorbent
wound dressings and for
moistening, debriding, and
cleaning acute and chronic
dermal lesions, such as Stage
I-IV pressure ulcers, stasis
ulcers, diabetic ulcers, foot
ulcers, post-surgical wounds,
first and second-degree burns,
cuts, abrasions, and minor skin
irritations and for device
irrigation. | Same |
| Technological
Characteristics | Mechanical action associated with
the application and movement of
fluid (either Sterile Water or
Saline) across a wound or device
surface to facilitate the
moisturizing, debridement, and
irrigation of these surfaces. | Mechanical action associated
with the application and
movement of fluid (either
Sterile Water or Saline) across a
wound or device surface to
facilitate the moisturizing,
debridement, and irrigation of
these surfaces. | Same |
### Table 1: General Comparison
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| Features
compared | Proposed Device | | Predicate Device | | Result |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Chemical
Composition | Sterile water USP or 0.9% Sterile
normal saline USP, no
antimicrobial or other substance
added. | | Sterile Saline (0.9% Sodium
Chloride) or Sterile Water for
irrigation substantiated to meet
USP; no antimicrobial or other
substance added. | | Same |
| Design
Configuration | Content | Container | Content | Container | Similar |
| | 100 mL Sterile
Water, USP
100 mL Sterile
0.9% Normal
Saline, USP
250 mL Sterile
Water, USP
500 mL Sterile
Water, USP
1000 mL
Sterile Water,
USP
250 mL Sterile
0.9% Normal
Saline, USP
500 mL Sterile
0.9% Normal
Saline, USP
1000 mL
Sterile 0.9%
Normal Saline,
USP | PP bottle with a
PP screw cap and
a PP/PET
aluminum
induction seal
PP bottles with a
PP screw cap
with a PP/PET
aluminum
induction seal
and a tamper
evident plastic
shrink wrap | 100 mL Sterile
water, USP
250 mL Sterile
water, USP
100 mL Normal
Saline, USP
250 mL Normal
Saline, USP
500 mL Sterile
Water, USP
500 mL Normal
Saline, USP | HDPE Bottles
made from
polyethylene
(PE) resin.
Include an
induction-heat
seal and liner
with a
polypropylene
(PP) screw
cap closure | |
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| Features
compared | Proposed Device | Predicate Device | Result |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance
Specifications | The sterile water USP and sterile
0.9% normal saline USP is
manufactured from respective
Water for Injection and Sodium
Chloride for injection that is
designed, tested and operated in
accordance with the USP
monographs: Water for injection
USP and Sodium Chloride USP. | The sterile water and sterile
saline is manufactured from
Water for Irrigation that is
designed, tested and operated
in accordance with the USP
monograph for Water for
Irrigation, as specified in USP
General Chapter: Water for
Pharmaceutical
Purposes
<1231> | Similar |
| Material of
packaging | PP Bottles | HDPE | Different |
| Sterilization | Terminal (STEAM) | Gamma Sterilization | Different |
| Shelf Life | 2 Years | 1 Year | Different |
# VIII.PERFORMANCE TESTING DATA
#### A. Biocompatibility Testing
The biocompatibility evaluation of the Sterile Water USP and Sterile 0.9% Normal Saline USP was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. The results of the evaluation, based on the tests outlined below, confirmed that the devices are biocompatible:
- . In Vitro Cytotoxicity (L929 Cell Line) conducted as per ISO 10993-5:2009, Third Edition: Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity
- Intracutaneous Reactivity conducted as per ISO 10993-23:2021, First Edition: Biological . Evaluation of Medical Devices: Tests for Irritation
- . Skin Sensitization (Guinea Pig Maximization Test) conducted as per ISO 10993-10:2021 Fourth Edition: Biological Evaluation of Medical Devices: Tests for Skin Sensitization
- Acute Systemic Toxicity (in Swiss Albino Mice) conducted as per ISO 10993-11:2017: ● Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- . Material Mediated Pyrogenicity test (in New Zealand white rabbits) conducted as per ISO 10993-11:2017: Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
#### B. Packaging and Transportation Testing
Packaging and transportation tests have been conducted to demonstrate that the complete packaging system used for Sterile Water, USP, and Sterile 0.9% Normal Saline, USP meets the
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required standards of effectiveness and quality. The Sterile water, USP and Sterile 0.9% Normal Saline, USP complies with the criteria for each test provided below, ensuring the product is safe for use:
- Visual inspection of seal (ANSI Z 1.4)- no defects identified. .
- Dye Migration Test (ASTM F1929-23)- no bottles exhibited leakage or deformation.
- Determination of leaks in flexible packaging by bubble emission (ASTM D3078-02)- No leakage detected and no variation in weight observed.
- . Internal Pressurization failure resistance of unrestrained packages (ASTM F1140)- no leakage observed.
- . Drop Test of Loaded Containers by Free fall (ASTM D5276-19)- Containers remained undamaged after the fall.
- Box compression Test (ASTM D642)- successfully withstood the maximum weight . stack.
#### C. Non- Clinical Performance Testing (Bench)
Sterile Water USP and Sterile 0.9% Normal Saline USP have been demonstrated to be both effective and safe for their intended purposes, as supported by the results of the non-clinical performance evaluations outlined below:
### Sterile Water USP
- o Total organic carbon USP <643>
- Water Conductivity USP <643> .
- . Sterility Test USP <71>
- Bacterial endotoxins Test USP <85> .
- . Appearance
- . Volume in Container
### Sterile 0.9% Normal Saline USP
- · Sodium Chloride Titration USP Monograph
- Identification USP <191>
- pH USP <791>
- Iron USP <241>
- · Volume in Container
- · Appearance
- · Sterility Test USP <71>
- Bacterial Endotoxins Test USP <85>
#### Clinical Test Data D.
No clinical study was conducted since clinical data is not necessary for Sterile Water USP and Sterile 0.9% Normal Saline USP.
### IX. CONCLUSION
Based on testing and comparison to the predicate device, Sterile Water USP and Sterile 0.9% Normal Saline USP for Irrigation are as safe and effective for their intended use as the predicate, Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP.
---
**Source:** [https://fda.innolitics.com/device/K243001](https://fda.innolitics.com/device/K243001)
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