Product code FXY— General, Plastic Surgery

FDA has cleared 13 devices under product code FXY between 1976 and 2023, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20201 clearance
• 20141 clearance
• 19904 clearances
• 19881 clearance
• 19772 clearances
• 19763 clearances

• Surgikos, Inc.2 clearances
• Stryker Corporation2 clearances
• Sherwood Medical Industries2 clearances
• Biomedical Devices, Inc.2 clearances
• Thi Total Healthcare Innovation GmbH1 clearance
• The Owenby Co.1 clearance
• James River Corp.1 clearance
• Chicago Assoc. For Retarded Citizens1 clearance
• Anago, Inc.1 clearance

• K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH·2023-10-17
• K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverStryker Corporation·2020-03-21
• K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSStryker Corporation·2014-06-26
• K904969 — HOOD, OPERATING, SURGICALChicago Assoc. For Retarded Citizens·1990-12-12
• K904276 — DISPOSABLE BEARD COVERAnago, Inc.·1990-11-21
• K903533 — STERI-SHIELDBiomedical Devices, Inc.·1990-10-19
• K902677 — STERI-SHIELDBiomedical Devices, Inc.·1990-08-17
• K880431 — CARETEX SURGEON'S HOODSJames River Corp.·1988-02-24
• K770261 — HOOD, CLARION SURGEONSSherwood Medical Industries·1977-03-01
• K770257 — HOOD & BEARD COVER, CLARION SURGEON'SSherwood Medical Industries·1977-02-25
• K761070 — P.S.M. SURGICAL HOODThe Owenby Co.·1976-12-30
• K760855 — BARRIER SURGICAL HOODSurgikos, Inc.·1976-11-03
• K760865 — BARRIER FASHION BONNETSurgikos, Inc.·1976-11-03