510(k) K931673

CARAPACE CATARACT TRAYS by Carapace, Inc. — Product Code LRO

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: December 30, 1993
Date Received: April 6, 1993
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 Carapace, Inc.

K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
K931729 — I.V. START KIT (February 22, 1994)
K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
K931670 — CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (January 25, 1994)

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)