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SofTIP 60-02

by Atricure, Inc. 3 variants

SofTIP 60-02 (FG-0008-02) is a Class II device made by Atricure, Inc., cleared under FDA 510(k) K090385 on 6 May 2009 and listed in FDA GUDID since 29 Jul 2021 (UDI-DI 10840143904417), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K090385

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10840143904417 UDI-DI Date29 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090385 Date6 May 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090385 decided 6 May 2009 Active
  • FDA GUDID UDI-DI 10840143904417 listed 29 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090385
  2. Listed FDA GUDID 10840143904417

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SofTIP
Generic name
Suture cutter, single-use
Model / Ref / Catalog
60-02, FG-0008-02
Primary DI / UDI-DI
10840143904417
510(k) Number
FDA product code
GAT
GMDN term
Suture cutter, single-use
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Suture cutter, single-use

Cleared under the same submission (K090385)

Similar devices

Other devices filed under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Other devices from Atricure, Inc.

See all devices from Atricure, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)