FXO
6 FDA 510(k) clearances · Product code
34 daysmedian time to decision
201 days90th percentile
6clearances measured
FDA profile
- Official device name
- Suit, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BTP(TM) CENTRALINE(TM) SUIT (K914615) | Btp Industries, Inc. | 1992-05-05 |
| APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE (K891212) | Pro-Safe Professional Linens, Inc. | 1989-04-14 |
| SUIT, SURGICAL (K882282) | A Plus International, Inc. | 1988-06-23 |
| SURGICAL GARMENTS (K865022) | Ulti-Med Intl., Inc. | 1987-01-12 |
| SPUNGUARD SCRUB SUIT (K831207) | Kimberly-Clark Corp. | 1983-05-16 |
| MULTIPLE SCRUB SUIT (K822483) | Surgilite Intl., Inc. | 1982-09-17 |
Track FXO automatically
Every clearance here is in the API, with alerts when new ones post.