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510(k) K993970

MICRINS MICROSURGICAL SUTURE by Micrins Surgical, Inc. — Product Code GAR

K993970 is an FDA 510(k) premarket notification submitted by Micrins Surgical, Inc. for the device "MICRINS MICROSURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on March 30, 2000. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Micrins Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2000
Date Received
November 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

Other clearances by Micrins Surgical, Inc.

  • K982278 — MICRINS MICRO ANASTOMOSIS CLAMP (March 26, 1999)
  • K933310 — MICRINS CONTRAST BACKGROUND MATERIAL (August 19, 1993)
  • K872989 — MICRINS NEEDLE HOLDER (August 21, 1987)
  • K872990 — MICRINS SURGICAL SCISSOR (August 17, 1987)
  • K872991 — MICRINS FORCEPS 2010 (August 17, 1987)

Other clearances for product code GAR

  • K261484 — Tissue Approximation System (June 3, 2026)
  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)

FDA data resources