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510(k) K951478

GENERAL AND PLASTIC SURGERY PACKS by Sterile Concepts, Inc. — Product Code LRO

K951478 is an FDA 510(k) premarket notification submitted by Sterile Concepts, Inc. for the device "GENERAL AND PLASTIC SURGERY PACKS". The FDA issued a decision of Substantially Equivalent on June 13, 1995. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Sterile Concepts, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
March 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Surgery Tray
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Other clearances by Sterile Concepts, Inc.

  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K951081 — OB/GYN PACKS (November 13, 1995)
  • K952539 — RADIOLOGY PACKS (July 14, 1995)
  • K944139 — DENTAL HYGIENE TRAY (December 15, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K943090 — SUTURE REMOVAL TRAYS (August 22, 1994)
  • K940864 — DENTIST WITH ASSISTANT PACK (August 2, 1994)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K920763 — LACERATTION TRAY (September 28, 1992)

Other clearances for product code LRO

  • K213481 — Medline General Surgery Tray (May 24, 2022)
  • K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
  • K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
  • K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (January 30, 1998)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)
  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)

FDA data resources