Home / 510(k) Clearances / K982646

510(k) K982646

AILEE SUTURES AND AILEE NEEDLES by Myco Medical Supplies, Inc. — Product Code GAL

K982646 is an FDA 510(k) premarket notification submitted by Myco Medical Supplies, Inc. for the device "AILEE SUTURES AND AILEE NEEDLES". The FDA issued a decision of Substantially Equivalent on June 2, 1999. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Myco Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1999
Date Received
July 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

Other clearances by Myco Medical Supplies, Inc.

  • K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal N (September 29, 2021)
  • K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (May 14, 2018)
  • K090426 — VAKU-8 BLOOD COLLECTION NEEDLES (June 12, 2009)
  • K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER (January 19, 2006)
  • K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET (April 12, 2001)
  • K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES (June 2, 2000)
  • K990388 — TUTOPLUS IV ADMINISTRATION SET (March 29, 1999)
  • K982098 — TUTODROP 1 AND TUTODROP 2 (March 1, 1999)
  • K963364 — GLASS VAN GLASS SYRINGES (May 1, 1998)
  • K953252 — DISPOSABLE SCALP VEIN INFUSION SET (November 26, 1996)

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K042287 — UNIPLAIN & UNICHROM (September 7, 2005)
  • K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (November 19, 2004)
  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)
  • K020597 — SERRALGUT (August 14, 2002)
  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K011105 — SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (May 30, 2001)
  • K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (June 23, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)

FDA data resources