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510(k) K931146

SURGICAL DRAPES, MODIFICATION by Amsco Sterile Recoveries, Inc. — Product Code KKX

K931146 is an FDA 510(k) premarket notification submitted by Amsco Sterile Recoveries, Inc. for the device "SURGICAL DRAPES, MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 13, 1994. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Amsco Sterile Recoveries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1994
Date Received
March 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical, Antimicrobial
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

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)
  • K931144 — STERILE SURGEON'S GOWN, MODIFICATION (June 10, 1994)
  • K931145 — NON-STERILE ISOLATION GOWN (June 10, 1994)
  • K931874 — RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE (June 10, 1994)
  • K931875 — AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE (June 10, 1994)
  • K932035 — NON-LINTING DELIVERY BLANKET (May 26, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)
  • K921049 — SURGICAL DRAPE (October 1, 1992)
  • K920404 — SURGEON'S GOWN (August 18, 1992)

Other clearances for product code KKX

  • K230645 — BeneHold™ Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)

FDA data resources