GDY · Gauze/Sponge, Internal, X-Ray Detectable
General, Plastic Surgery · 21 CFR 878.4450 · Class 1
Overview
| Product Code | GDY |
|---|---|
| Device Name | Gauze/Sponge, Internal, X-Ray Detectable |
| Regulation | 21 CFR 878.4450 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.
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 § 878.9.
Recent Cleared Devices (20 of 111)
Showing 20 most recent of 111 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972634 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | Dec 17, 1997 | SESE |
| K960236 | CPR LAP SPONGES | Custom Pack Reliability | Mar 28, 1996 | SESE |
| K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | Stryker Corp. | Feb 22, 1996 | SESE |
| K955322 | PROTEC X-RAY DETECTABLE GAUZE SPONGE | Derivados DE Gasa, S.A. DE C.V. | Dec 19, 1995 | SESE |
| K953830 | KENSORB | Kentron Health Care, Inc. | Oct 3, 1995 | SESE |
| K953088 | TRIANGULAR SPONGES | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K953087 | CHERRY PIT DISSECTOR | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K953062 | CHERRY DISSECTOR | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K953060 | ROSEBUD DISSECTOR | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K953059 | KITTNER DISSECTOR | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K953057 | CYLINDRICAL SPONGE | Medical Perspectives Corp. | Sep 14, 1995 | SESE |
| K951911 | GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Commercial Resources New Mexico, Ltd. | Jun 21, 1995 | SESE |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | Apr 17, 1995 | SESE |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | Apr 17, 1995 | SESE |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | Apr 17, 1995 | SESE |
| K950659 | ULTRACELL RETRACTOR COVERS | Ultracell Medical Technologies, Inc. | Apr 13, 1995 | SESE |
| K945866 | CYLINDRICAL SPONGE | Lorrex Health Products | Dec 28, 1994 | SESE |
| K945606 | TRIANGULAR SPONGES | Lorrex Health Products | Dec 28, 1994 | SESE |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Lorrex Health Products | Dec 28, 1994 | SESE |
Top Applicants
- Lorrex Health Products — 9 clearances
- Ultracell Medical Technologies, Inc. — 7 clearances
- Thantex Specialties, Inc. — 7 clearances
- Medical Perspectives Corp. — 7 clearances
- Mcneil Healthcare, Inc. — 5 clearances
