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510(k) K971089

OPPORTUNITY, INC. LACERATION TRAY by Opportunity, Inc. — Product Code KKX

K971089 is an FDA 510(k) premarket notification submitted by Opportunity, Inc. for the device "OPPORTUNITY, INC. LACERATION TRAY". The FDA issued a decision of SN on September 16, 1997. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Opportunity, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 16, 1997
Date Received
March 24, 1997
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 Opportunity, Inc.

  • K971093 — OPPORTUNITY I.V. START KIT (September 16, 1997)
  • K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY (September 16, 1997)
  • K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT (September 16, 1997)
  • K971090 — OPPORTUNITY DRESSING CHANGE TRAY (September 16, 1997)
  • K971095 — OPPORTUNITY SUTURE REMOVAL KIT (September 16, 1997)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)

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