# Vision-Sciences, Inc.

- Location (FDA's records): Natick, MA
- FDA decisions: 33 (1986–2011): 33 510(k) clearances
- Product codes: EOB (15), FAM (5), FAJ (3), EOQ (3), EOX (3), FDF (1), HQG (1), HIH (1), FDS (1)
- Predicates its devices cite: 68 (59 its own); citations of its devices by later devices: 104 (59 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pentax Precision Instrument Corp.: 2 (https://510kreport.com/company/pentax-precision-instrument)
- Olympus Corp.: 2 (https://510kreport.com/company/olympus)
- Axis Surgical Technologies, Inc.: 1 (https://510kreport.com/company/axis-surgical-technologies)
- Biomet Orthopedics, Inc.: 1 (https://510kreport.com/company/biomet-orthopedics)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Spine View, Inc.: 1 (https://510kreport.com/company/spine-view)
- Optim, LLC: 1 (https://510kreport.com/company/optim)

## Firms that cite its devices most
- Rtc Inc.-Memcath Technologies, LLC: 10 (https://510kreport.com/company/rtc-memcath-technologies)
- Cogentix Medical, Inc.: 5 (https://510kreport.com/company/cogentix-medical)
- Akos Biomedical, Inc.: 4 (https://510kreport.com/company/akos-biomedical)
- Sightline Technologies, Ltd.: 4 (https://510kreport.com/company/sightline-technologies)
- Intromedic Co., Ltd.: 3 (https://510kreport.com/company/intromedic)
- Optim, LLC: 3 (https://510kreport.com/company/optim)
- Ambu A/S: 2 (https://510kreport.com/company/ambu-a-s)
- Spine View, Inc.: 2 (https://510kreport.com/company/spine-view)

## Its most-cited devices
- K990354: Endosheath (1999), cited by 12
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System (2003), cited by 8
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System (2002), cited by 7
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor (2007), cited by 6
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), cited by 5
- K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System (2004), cited by 5

## Recent decisions
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (May 18, 2011)
- K100125: Vision Sciences Flexible Ent Scope (Feb 25, 2010)
- K091768: Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor & Accessories (Aug 3, 2009)
- K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System (Dec 18, 2007)
- K071127: Flexible Hysteroscope with Endosheath System (Nov 16, 2007)
- K072088: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems (Aug 29, 2007)
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor (Aug 29, 2007)
- K071903: Endosheath Systems for Use with Vision-Sciences Tne Scope (Aug 2, 2007)

Source page: https://510kreport.com/company/vision-sciences