510(k) K933137

ACU-SUTURE KIT by Acuderm, Inc. — Product Code LRO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 22, 1994
Date Received: June 28, 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 Acuderm, Inc.

K933516 — ACU-E PUNCH (March 24, 1994)
K933265 — ACU-DISPO-CE(TM) (March 7, 1994)
K930043 — ACU-EVAC (February 9, 1994)
K933866 — ACU-HEMOSTATIC RING (December 1, 1993)
K915000 — ACU-GUARD (January 27, 1992)
K891334 — ACU-CURETTE (April 11, 1989)
K874024 — ACU-MICRO-NEEDLE (November 23, 1987)
K854877 — ACU-SYRINGE W/WO NEEDLES (February 19, 1986)
K832583 — SABOURAUD DEXTROSE AGAR (September 12, 1983)
K832582 — MYCOSEL AGAR (September 12, 1983)

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)