# Henke-Sass, Wolf GmbH

- Location (FDA's records): Tuttlingen, DE
- FDA decisions: 6 (1994–2018): 6 510(k) clearances
- Product codes: HIH (2), GCJ (1), FMF (1), FAJ (1), FHO (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Endoscopy: 2 (https://510kreport.com/company/stryker-endoscopy)
- C. B. Dumont Company, Inc.: 1 (https://510kreport.com/company/c-b-dumont)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)

## Firms that cite its devices most
- Henke Sass Wolf of America, Inc.: 2 (https://510kreport.com/company/henke-sass-wolf-of-america)
- Arthro Kinetics, Inc.: 1 (https://510kreport.com/company/arthro-kinetics)
- Interlace Medical, Inc.: 1 (https://510kreport.com/company/interlace-medical)
- Rz Medizintechnik GmbH: 1 (https://510kreport.com/company/rz-medizintechnik)
- American Medical Endoscopy, Inc.: 1 (https://510kreport.com/company/american-medical-endoscopy)
- Ocuject, LLC: 1 (https://510kreport.com/company/ocuject)

## Its most-cited devices
- K941967: HSW Laparoscope and Accessories (1994), cited by 3
- K173070: HSW Resection Instruments (2018), cited by 1
- K952186: HSW GMBH Hysteroscopes & Accessories (1996), cited by 1
- K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet) (2010), cited by 1
- K171336: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath (2017), cited by 1

## Recent decisions
- K173070: HSW Resection Instruments (Jun 8, 2018)
- K171336: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath (Dec 7, 2017)
- K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet) (Nov 22, 2010)
- K952186: HSW GMBH Hysteroscopes & Accessories (Feb 6, 1996)
- K943624: Elmed Pneumoperitoneum Needles (Aug 10, 1994)
- K941967: HSW Laparoscope and Accessories (May 16, 1994)

Source page: https://510kreport.com/company/henke-sass-wolf