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Hermetic™ INS8600

by Integra Lifesciences Corp. 2 variants

Hermetic™ INS8600 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K972994 on 3 Nov 1997 and listed in FDA GUDID since 28 Jun 2024 (UDI-DI 10381780537496), 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) K972994

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 Number10381780537496 UDI-DI Date28 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK972994 Date3 Nov 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K972994 decided 3 Nov 1997 Active
  • FDA GUDID UDI-DI 10381780537496 listed 28 Jun 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K972994
  2. Listed FDA GUDID 10381780537496

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hermetic™
Generic name
Ventricular cerebrospinal fluid drainage catheterization kit
Model / Ref / Catalog
INS8600
Primary DI / UDI-DI
10381780537496
510(k) Number
FDA product code
JXG
GMDN term
Ventricular cerebrospinal fluid drainage catheterization kit
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit

Cleared under the same submission (K972994)

and 8 more cleared under K972994

Similar devices in this category

Other devices filed under Ventricular cerebrospinal fluid drainage catheterization kit.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

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