Who is the manufacturer of gel-e Bandage?

Gel-E, Inc. (Formerly Remedium Technologies, Inc.) filed the 510(k) submission for gel-e Bandage (K172010).

What is the FDA product code for gel-e Bandage?

KGN. as a Class U device in the SU panel.

What is the regulatory pathway for gel-e Bandage?

510(k) clearance (submission type: Traditional).

What are the predicate devices for gel-e Bandage?

KA01 Chitosan Wound Dressing (K143124).

Who can help prepare an FDA 510(k) submission like gel-e Bandage?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

gel-e Bandage

K172010 · Gel-E, Inc. (Formerly Remedium Technologies, Inc.) · KGN · Dec 7, 2017 · SU

Device Facts

Record ID	K172010
Device Name	gel-e Bandage
Applicant	Gel-E, Inc. (Formerly Remedium Technologies, Inc.)
Product Code	KGN · SU
Decision Date	Dec 7, 2017
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Bandage may be used for management of: Pressure sores Diabetic ulcers Leg ulcers Donor sites and graft sites Surgical wounds Skin abrasions and lacerations 1st and 2nd degree burns Trauma wounds. The gel-e Bandage may be used for the management of: Minor cuts Minor scalds and 1st degree burns Abrasions Lacerations.

Device Story

Sterile topical bandage; lyophilized chitosan-based patch attached to flexible woven cellulosic fabric backing with adhesive strips. Used as primary dressing for chronic/acute wounds; applied by manually pressing adhesive strips to skin. Absorbs wound exudate; chitosan patch forms gel upon contact with moisture; maintains moist wound environment; facilitates intact removal. Used in clinical or home settings; applied by clinician or patient. Benefits include exudate management and moist healing environment.

Clinical Evidence

Bench testing only. Evidence includes comparative animal testing, bench testing (pH, absorbency, moisture content), biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity), packaging (burst pressure, dye penetration), sterilization validation, and real-time shelf-life stability testing.

Technological Characteristics

Sterile, non-woven palmitoyl-N-acetylglucosamine (chitosan) patch; cellulosic polymer; flexible woven cellulosic fabric adhesive backing. Dimensions: 19mm x 76mm (12mm x 25mm patch). Sterilization: Gamma radiation (SAL 10^-6). Single-use.

Indications for Use

Indicated for management of moderately to heavily exuding chronic and acute wounds, including pressure sores, diabetic/leg ulcers, donor/graft sites, surgical wounds, abrasions, lacerations, 1st/2nd degree burns, and trauma wounds. OTC use indicated for minor cuts, minor scalds, 1st degree burns, abrasions, and lacerations.

Predicate Devices

KA01 Chitosan Wound Dressing (K143124)

Reference Devices

Hemogrip™ Patch (K143466)

Related Devices

K143124 — KA01 Chitosan Wound Dressing · Foshan United Medical Technologies, Ltd. · Jan 26, 2015
K212766 — Maxiocel Chitosan Wound Dressing · Advamedica, Inc. · Aug 24, 2023
K173005 — SURECELL Gelling Fiber Wound Dressing · Jiangsu Newvalue Medical Producst Co.,Ltd · May 25, 2018
K252001 — Collagen Wound Dressing · Winner Medical Co., Ltd. · Oct 10, 2025
K970453 — B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING · B.Braun Medical, Inc. · Apr 11, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ December 7, 2017 gel-e, Inc. (formerly Remedium Technologies, Inc.) % Elsa Abruzzo CEO Cygnus Regulatory Cincinnati, Ohio 45226 Re: K172010 Trade/Device Name: gel-e Bandage Regulatory Class: Unclassified Product Code: FRO Dated: October 20, 2017 Received: October 30, 2017 Dear Elsa Abruzzo: 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 (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. 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. 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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K172010 Device Name gel-e Bandage Indications for Use (Describe) The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds. Under medical supervision, the gel-e Bandage may be used for management of: - · Pressure sores - · Diabetic ulcers - · Leg ulcers - · Donor sites and graft sites - · Surgical wounds - Skin abrasions and lacerations - 1st and 2nd degree burns - · Trauma wounds | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K172010 Device Name gel-e Bandage Indications for Use (Describe) The gel-e Bandage may be used for the management of: - Minor cuts - · Minor scalds and 1st degree burns - · Abrasions - · Lacerations Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### K172010 GEL-E BANDAGE 510(k) Summary ## 510(k) Summary | A. Name and Address of Applicant : | gel-e, Inc. (formerly Remedium Technologies) 387 Technology Dr., Suite 3110B College Park, MD 20742 | |------------------------------------|-----------------------------------------------------------------------------------------------------------| | B. Contact Person: | Matthew Dowling, PhD Chief Scientific Officer Phone: (301) 405-3585 Fax: (301) 314-9592 | | C. Date of Submission : | June 30, 2017 | | D. Device Trade Name: | gel-e Bandage | | E. Device Common Name: | Dressing, Wound, Drug | | F. Device Classification: | Unclassified Device (pre-amendment) | | G. Classification Name: | Unclassified | | H. Product Code: | FRO | | I. Predicate Device: | Primary: Foshan United Medical Technologies' KA01 Chitosan Wound Dressing (K143124) | | J. Reference Device: | gel-e's Hemogrip™ Patch (K143466) | - K. Intended Use: #### Prescription Use (21 CFR 801 Subpart D) The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of: - Pressure sores - Diabetic ulcers - Leg ulcers - · Donor sites and graft sites - Surgical wounds - Skin abrasions and lacerations {5}------------------------------------------------ - 1st and 2nd degree burns - Trauma wounds Over-The-Counter Use (21 CFR 801 Subpart C): - The gel-e Bandage may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns - · Abrasions - · Lacerations - L. Device Description: Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal. The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6. - M. Performance Data Representative samples of the device underwent testing including comparative animal testing, bench testing (pH, absorbency, moisture content), biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity), packaging testing (burst pressure and dye penetration testing), sterilization validation testing, and shelf-life stability testing (real time). The performance data from this pre-clinical testing demonstrates that the gel-e Bandage is substantially equivalent to the predicate device. - N. Summary of Substantial Equivalence: Gel-e has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the gel-e Bandage is substantially equivalent to the currently marketed predicate device. Gel-e Bandage has essentially the same intended use/indication for use as the predicate device. Moreover, the gel-e Bandage has similar patient contacting materials and technology as the reference device, Hemogrip Patch. {6}------------------------------------------------ | | Gel-e Bandage (Subject Device) | KA01 Chitosan Wound Dressing (Predicate Device) | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K Number | K172010 | K143124 | | Manufacturer | Gel-e, Inc. | Foshan United Medical Technologies | | Classification | Unclassified | Unclassified | | Product Code | FRO | FRO | | Indications for Use | The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Bandage may be used for management of: • Pressure sores • Diabetic ulcers • Leg ulcers • Donor sites and graft sites • Surgical wounds • Skin abrasions and lacerations • 1st and 2nd degree burns • Trauma wounds OTC: The gel-e Bandage may be used for the management of: • Minor cuts • Minor scalds and 1st degree burns • Abrasions • Lacerations | The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for management of: • Pressure sores • Diabetic ulcers • Leg ulcers • Donor sites and graft sites • Surgical wounds • Skin abrasions and lacerations • 1st and 2nd degree burns • Trauma wounds OTC: The KA01 Chitosan Wound Dressing may be used for the management of: • Minor cuts • Minor scalds and 1st degree burns • Abrasions • Lacerations | | Device Design | Single layer, non-woven pad attached to skin-adhesive backing | Absorbable, single layer, needle punched non-woven pad or ribbon dressing that can be cut or folded | | Material | Gel-e Bandage is composed of a soft, sterile, non- woven palmitoyl-N-acetylglucomasine (chitosan), a cellulosic polymer, with a skin-adhesive backing made of flexible woven cellulosic fabric for simple application | The KA01 Chitosan Wound Dressing is a soft, sterile, non-woven poly-N- acetylglucosamine (chitosan), a cellulosic biopolymer. | | Physical Characteristics | Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosan-based patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosan-based patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal. | The KA01 Chitosan Wound Dressing is a sterile non- woven chitosan dressing comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal. | | Size | 19 mm x 76 mm (12 mm x 25 mm patch in center) | 25 mm x 25 mm 40 mm x 40 mm | | Thickness | 3 mm (patch) | 5 mm 5 mm | | Weight | 0.4 g | 0.5 g 0.8 g | | Sterility | 106 SAL - Terminally sterilized with gamma radiation, for single use only | 106 SAL - Terminally sterilized with gamma radiation, for single use only | | Biocompatibility Testing | Cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity | Cytotoxicity, irritation, sensitization, systemic toxicity | | Performance Testing | pH, moisture content, absorbency | pH, moisture content, absorbency | Results of scientific testing have ensured that all materials are biocompatible and physical properties are appropriate for the intended use. Non-clinical testing was conducted. In conclusion, gel-e, Inc. considers the gel-e Bandage to be equivalent to the primary predicate device listed above based upon the device's similarities in intended use, design, mechanism of action, technology and materials.