# Henke Sass Wolf of America, Inc.

- Location (FDA's records): Southbridge, MA
- FDA decisions: 9 (1994–2008): 9 510(k) clearances
- Product codes: GCJ (3), HRX (2), EOB (2), FMI (1), HIH (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 11 (1 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
- Henke-Sass, Wolf GmbH: 2 (https://510kreport.com/company/henke-sass-wolf)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Richards, Inc.: 1 (https://510kreport.com/company/smith-nephew-richards)
- Richards Medical Co., Inc.: 1 (https://510kreport.com/company/richards-medical)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Interlace Medical, Inc.: 2 (https://510kreport.com/company/interlace-medical)
- Microaire Surgical Instruments, LLC: 1 (https://510kreport.com/company/microaire-surgical-instruments)
- Iogyn, Inc.: 1 (https://510kreport.com/company/iogyn)
- Myelotec, Inc.: 1 (https://510kreport.com/company/myelotec)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Asap Endoscopic Products GmbH: 1 (https://510kreport.com/company/asap-endoscopic-products)

## Its most-cited devices
- K080560: Henke Sass Wolf of America Arthroscope (2008), cited by 4
- K941541: HSV Laparoscopy Set (1994), cited by 2
- K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C (1999), cited by 2
- K962075: HSW GMBH Arthroscope (1997), cited by 1
- K981751: Sinuscope and Accessories (1998), cited by 1
- K050163: Henke Sass Wolf of America Bariatric Laparoscope (2005), cited by 1

## Recent decisions
- K080560: Henke Sass Wolf of America Arthroscope (Mar 18, 2008)
- K050163: Henke Sass Wolf of America Bariatric Laparoscope (Mar 24, 2005)
- K030572: Henke Sass Wolf of America Nasopharyngoscope (Apr 1, 2003)
- K013611: Henke Sass Wolf Saphenous Vein Laparoscope (Feb 1, 2002)
- K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C (Oct 13, 1999)
- K983067: Fine-Ject (Oct 30, 1998)
- K981751: Sinuscope and Accessories (Aug 13, 1998)
- K962075: HSW GMBH Arthroscope (Jan 17, 1997)

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