Product code FXO— General, Plastic Surgery

FDA has cleared 6 devices under product code FXO between 1982 and 1992, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19921 clearance
• 19891 clearance
• 19881 clearance
• 19871 clearance
• 19831 clearance
• 19821 clearance

• Ulti-Med Intl., Inc.1 clearance
• Surgilite Intl., Inc.1 clearance
• Pro-Safe Professional Linens, Inc.1 clearance
• Kimberly-Clark Corp.1 clearance
• Btp Industries, Inc.1 clearance
• A Plus International, Inc.1 clearance

• K914615 — BTP(TM) CENTRALINE(TM) SUITBtp Industries, Inc.·1992-05-05
• K891212 — APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPEPro-Safe Professional Linens, Inc.·1989-04-14
• K882282 — SUIT, SURGICALA Plus International, Inc.·1988-06-23
• K865022 — SURGICAL GARMENTSUlti-Med Intl., Inc.·1987-01-12
• K831207 — SPUNGUARD SCRUB SUITKimberly-Clark Corp.·1983-05-16
• K822483 — MULTIPLE SCRUB SUITSurgilite Intl., Inc.·1982-09-17