# Prosurg, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 16 (2000–2016): 16 510(k) clearances
- Product codes: FAJ (2), JEY (2), GEX (2), FTL (2), GCJ (1), FAS (1), LKY (1), NBV (1), LKF (1), HRX (1), GXR (1), EOQ (1)
- 510(k) review time since 2016: median 262 days, against 99 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 4 (4 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
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Inion, Ltd.: 1 (https://510kreport.com/company/inion)
- Biotech One, Inc.: 1 (https://510kreport.com/company/biotech-one)
- Integrated Endoscopy, Inc.: 1 (https://510kreport.com/company/integrated-endoscopy)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- Biolitec, Inc.: 1 (https://510kreport.com/company/biolitec)
- Injectx, Inc.: 1 (https://510kreport.com/company/injectx)
- American Medical Systems, Inc.: 1 (https://510kreport.com/company/american-medical-systems)

## Its most-cited devices
- K120766: Endoscopic Diagnostic & Treatment System (Modification) (2012), cited by 1
- K070737: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories (2007), cited by 1
- K042780: Neoscope - Endoscopic Diagnostic & Treatment System (2005), cited by 1
- K030631: Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh (2003), cited by 1

## Recent decisions
- K152511: Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula (Jul 11, 2016)
- K152466: Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible) (May 19, 2016)
- K152619: Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) (Apr 29, 2016)
- K120766: Endoscopic Diagnostic & Treatment System (Modification) (Sep 11, 2012)
- K072528: Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & Accessories (Dec 28, 2007)
- K071138: Cranioclamp Bioabsorbable Cranial Bone Flap Fixation System (Aug 15, 2007)
- K070737: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories (Jul 25, 2007)
- K070846: Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System (Jul 2, 2007)

Source page: https://510kreport.com/company/prosurg