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510(k) K925815

REUSABLE LIQUIDPROOF BOOTIE by Amsco Sterile Recoveries, Inc. — Product Code FXP

K925815 is an FDA 510(k) premarket notification submitted by Amsco Sterile Recoveries, Inc. for the device "REUSABLE LIQUIDPROOF BOOTIE". The FDA issued a decision of Substantially Equivalent on July 9, 1993. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I 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
July 9, 1993
Date Received
November 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Shoe, Operating-Room
Device Class
Class I
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)
  • K921049 — SURGICAL DRAPE (October 1, 1992)
  • K920404 — SURGEON'S GOWN (August 18, 1992)

Other clearances for product code FXP

  • K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)
  • K971191 — FAR-EAST SHOE COVERS (July 10, 1997)
  • K970815 — CONVERTORS IMPERVIOUS SHOE COVERS (March 27, 1997)
  • K961342 — SHOE COVER, NON-STERILE (December 30, 1996)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K932738 — KAPPLER PRO/VENT BOOT (March 29, 1994)
  • K914702 — STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (January 29, 1993)

FDA data resources