KYZ · Syringe, Irrigating (Non Dental)
General Hospital · 21 CFR 880.6960 · Class 1
Overview
| Product Code | KYZ |
|---|---|
| Device Name | Syringe, Irrigating (Non Dental) |
| Regulation | 21 CFR 880.6960 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | Nov 5, 2020 | SESE |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Micromedics, Inc. | Mar 15, 2011 | SESE |
| K092022 | TISSU TRANS HARVEST TUBING | Shippert Medical Technologies Corp. | Aug 17, 2009 | SESE |
| K050797 | TISSU-TRANS | Shippert Medical Technologies Corp. | Jul 13, 2005 | SESE |
| K991254 | QS DELIVERY SYSTEM | Sub-Q, Inc. | Aug 23, 1999 | SESE |
| K982435 | IRRIGATION SYRINGE KIT | Sub-Q, Inc. | Nov 6, 1998 | SESE |
| K974288 | ZEROWET SPLASHIELD | Zerowet, Inc. | Jan 29, 1998 | SESE |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Research Medical, Inc. | Feb 19, 1997 | SESE |
| K960725 | MARPP PRESSURE MONITORING SYSTEM | Paradigm Medical, Inc. | Jul 15, 1996 | SESE |
| K960212 | CPR IRRIGATION TRAY | Custom Pack Reliability | Apr 1, 1996 | SESE |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | Contour Fabricators of Florida, Inc. | Aug 7, 1995 | SESE |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | Aug 7, 1995 | SESE |
| K933171 | INMAN IRRIGATION TAPERED PROBE | Inman Medical Corp. | Apr 29, 1994 | SESE |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | Micromedics, Inc. | Apr 6, 1994 | SESE |
| K930610 | TALC DISPENSER SYRINGE | Nusurg, Inc. | Nov 4, 1993 | SESE |
| K924517 | AVITENE DISPENSER SYRINGE | Nusurg, Inc. | Oct 27, 1993 | SESE |
| K931912 | IRRIGATING BLUNT DISSECTOR | Mayaguez Medical Center | Aug 10, 1993 | SESE |
| K931946 | WELCH ALLYN EARCLEANER | Welch Allyn, Inc. | Jul 26, 1993 | SESE |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | Customed, Inc. | Jun 7, 1993 | SEKD |
| K905173 | SPLASH GUARD | E.M. Adams | Apr 25, 1991 | SESE |
Top Applicants
- Micromedics, Inc. — 4 clearances
- Contour Fabricators of Florida, Inc. — 2 clearances
- Instrument Makar, Inc. — 2 clearances
- Nusurg, Inc. — 2 clearances
- Shippert Medical Technologies Corp. — 2 clearances
