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510(k) K920404

SURGEON'S GOWN by Amsco Sterile Recoveries, Inc. — Product Code FYC

K920404 is an FDA 510(k) premarket notification submitted by Amsco Sterile Recoveries, Inc. for the device "SURGEON'S GOWN". The FDA issued a decision of Substantially Equivalent on August 18, 1992. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Amsco Sterile Recoveries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1992
Date Received
January 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Amsco Sterile Recoveries, Inc.

  • K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS (September 9, 1994)
  • K931143 — AMSCO STERILE RECOVERIES ABSORBENT TOWELS (September 8, 1994)
  • K931146 — SURGICAL DRAPES, MODIFICATION (June 13, 1994)
  • K931145 — NON-STERILE ISOLATION GOWN (June 10, 1994)
  • K931875 — AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE (June 10, 1994)
  • K931874 — RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE (June 10, 1994)
  • K931144 — STERILE SURGEON'S GOWN, MODIFICATION (June 10, 1994)
  • K932035 — NON-LINTING DELIVERY BLANKET (May 26, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)
  • K921049 — SURGICAL DRAPE (October 1, 1992)

Other clearances for product code FYC

  • K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI (May 16, 2024)
  • K230135 — Copioumed Chemotherapy Isolation Gown (October 4, 2023)
  • K223467 — Disposable Isolation Gown (February 10, 2023)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (February 8, 2023)
  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (January 4, 2023)
  • K212717 — Paneffort AAMI Level 3 Isolation Gown (November 30, 2022)
  • K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable G (October 21, 2022)
  • K214116 — AAMI4 Isolation Gown (October 11, 2022)
  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (August 12, 2022)
  • K220528 — Surgical Isolation Cover Gown (June 10, 2022)

FDA data resources