Product code GDY
- Device name
- Gauze/Sponge, Internal, X-Ray Detectable
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4450
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972634 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| K960236 | CPR LAP SPONGES | Custom Pack Reliability | 1996-03-28 |
| K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | Stryker Corp. | 1996-02-22 |
| K955322 | PROTEC X-RAY DETECTABLE GAUZE SPONGE | Derivados DE Gasa, S.A. DE C.V. | 1995-12-19 |
| K953830 | KENSORB | Kentron Health Care, Inc. | 1995-10-03 |
| K953088 | TRIANGULAR SPONGES | Medical Perspectives Corp. | 1995-09-14 |
| K953087 | CHERRY PIT DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953062 | CHERRY DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953060 | ROSEBUD DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953059 | KITTNER DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES | Medical Perspectives Corp. | 1995-09-14 |
| K953057 | CYLINDRICAL SPONGE | Medical Perspectives Corp. | 1995-09-14 |
| K951911 | GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Commercial Resources New Mexico, Ltd. | 1995-06-21 |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 |
| K950659 | ULTRACELL RETRACTOR COVERS | Ultracell Medical Technologies, Inc. | 1995-04-13 |
| K945866 | CYLINDRICAL SPONGE | Lorrex Health Products | 1994-12-28 |
| K945606 | TRIANGULAR SPONGES | Lorrex Health Products | 1994-12-28 |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Lorrex Health Products | 1994-12-28 |
| K945335 | CHERRY DISSECTOR | Lorrex Health Products | 1994-12-28 |
| K945333 | KITTNER DISSECTOR | Lorrex Health Products | 1994-12-28 |
| K944879 | GAUZE SPONGES | Clinical Resources, Inc. | 1994-12-23 |
| K940767 | OREX (12X12 X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-12-19 |
| K940766 | OREX (18X18 X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-12-19 |
| K940764 | OREX | Thantex Specialties, Inc. | 1994-12-19 |
| K945334 | CHERRY PIT DISSECTOR | Lorrex Health Products | 1994-12-05 |
| K945336 | PEANUT DISSECTOR | Lorrex Health Products | 1994-12-05 |
| K945332 | ROSEBUD DISSECTOR | Lorrex Health Products | 1994-12-05 |
| K940436 | SPONGE, LAPAROTOMY, VARIOUS SIZE | Shawnee Products, Inc. | 1994-07-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327465853 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2025-09-03 |
| 07613327405484 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327423907 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327423891 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327423884 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405699 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405675 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405644 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405637 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405613 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405606 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405576 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405545 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405514 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405491 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613153089704 | ACM | STRYKER CORPORATION | 2018-09-24 |
| 07613327405477 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405460 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405439 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405422 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405415 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405408 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405378 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405354 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405330 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405323 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405316 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405309 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405293 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |
| 07613327405286 | SurgiCount Safety-Sponge | STRYKER CORPORATION | 2018-09-24 |