Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1648701

FEI Number

3000204261

Entity Name

KLEIN SURGICAL SYSTEMS, INC.

City/State/Country

San Antonio, TX, US

Establishment Address

400 N Loop 1604 E Ste 106, San Antonio, TX 78232, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

KLEIN SURGICAL SYSTEMS, INC. (Owner Number: 9026062)

Owner / Operator Contact Address

400 N Loop 1604 E,, Suite 106, San Antonio, TX 78232, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K930496

PMA Number

N/A

All Registered Proprietary Names

Satinsky Laproscopic Clamp TC Needle Holder Klein Bulldog Clamp Applier Klein Bulldogs Solos Applier GI-1088 AKA 300-400-775 Klein Applier GI-1085 AKA 300-100-771, GI-1086 AKA 300-100-772, GI-1085 AKA GI-1085U, GI-1095 AKA GI-1095U GI-1090, 1095, 1080, 1085, 1086, 1088, ENDOSCOPIC CLAMPS GI-1090 AKA 300-100-773, GI-1095 AKA 300-100-774, Solos Bulldogs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2023-07-10
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2023-07-10
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2023-07-10
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2011-03-03

Official Correspondent

RICHARD KLEIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KLEIN SURGICAL SYSTEMS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1648701. Last updated year: 2026. Please use registration number 1648701 when referencing this establishment in official correspondence.