Surgistar 8120

by Surgistar Inc.

Surgistar 8120 is a Class I device made by Surgistar Inc., cleared under FDA 510(k) K923689 on 9 Sep 1992 and listed in FDA GUDID since 7 Jul 2016 (UDI-DI 00878799002716), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00878799002716 UDI-DI	Date7 Jul 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK923689	Date9 Sep 1992Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00878799002716
FDA 510(k) database 510(k) number K923689

Across registries

2 registries list this device

FDA 510(k) K923689 decided 9 Sep 1992 Active
FDA GUDID UDI-DI 00878799002716 listed 7 Jul 2016 Listed

Timeline

2 dated events

9 Sep 1992 Cleared FDA 510(k) K923689
7 Jul 2016 Listed FDA GUDID 00878799002716

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Surgistar
Generic name: Manual scalpel blade, single-use
Model / reference: 8120

Primary DI / UDI-DI: 00878799002716
510(k) Number: K923689
FDA product code: GDX
GMDN term: Manual scalpel blade, single-use

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Lot / batch number
Expiration date

Other properties (11, all answered No)