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Surgin Kit

by Surgin Surgical Instrumentation, Inc.

510(k) K980849

Surgin Kit is a medical device (FDA Class II; FDA product code MSR, Tubing, Replacement, Phacofragmentation Unit) made by Surgin Surgical Instrumentation, Inc., cleared under FDA 510(k) K980849 on 9 Jul 1998, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980849 Date9 Jul 1998ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MSR
Device class
Class II
Regulation
21 CFR Part 886.4150
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MSR (Tubing, Replacement, Phacofragmentation Unit).

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