Data / Medical devices / United States / Carefree Surgical Specialties, Inc.
Carefree Surgical Specialties, Inc.: FDA-registered device maker in Nampa, ID, United States, 1 510(k) clearance
Carefree Surgical Specialties, Inc. is registered with the FDA (registration 2951379) in Nampa, ID, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 1988. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2951379
- FEI number
- 1000221450
- Address
- 1123 12th Ave Rd Suite 341, Nampa, ID, United States, 83686
- Owner or operator
- Carefree Surgical Specialties, Inc. (10093644)
- Roles
- Specification developer
- First device listed
- June 16, 2025
- Registered through
- 2027
- Brand names listed
- Sterile Kittner Roll Gauze
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 1988 | K882708 | GAUZE SPONGE, X-RAY DETECTABLE | GDY | Substantially Equivalent | Bioseal | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 1, 2025 | 97259 | Class II | Ongoing | 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: Robotic/Laparoscopy Kit | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging | accessdata.fda.gov |
Compare with other makers
Updated August 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.