3DSCOPE— 510(k) K923160
Substantially EquivalentAmerican Surgical Technologies Corp.
FDA 510(k) clearance K923160 for 3DSCOPE, Substantially Equivalent on 1992-12-10. Applicant: American Surgical Technologies Corp.. Device class: 1.
Clearance details
- Applicant
- American Surgical Technologies Corp.
- Product code
- Code FWF
- Device class
- Class 1
- Regulation
- 21 CFR 878.4160
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haverhiill, MA, US
Recent devices under product code FWF
view all- K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC
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- K982754 — EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
- K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
- K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.