510(k) K882708 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
GAUZE SPONGE, X-RAY DETECTABLE
| Applicant | Bioseal, Brea CA, US |
| Decision | Substantially Equivalent, Aug 3, 1988 |
| Received | Jun 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Model/Catalog Number: 15508/25
Product Description: Ro Open, Classified |
GDY | None listed |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
Model/Catalog Number: 15505/25
Product Description: Roboti Open, Classified |
GDY | None listed |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
Model/Catalog Number: 15505/25
Product Description: Roboti Open, Classified |
GDY | None listed |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Model/Catalog Number: 15506/25
Product Des Open, Classified |
GDY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.