FDA.reportPublic FDA data

ENVISION ENDOSCOPY INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
ENVISION ENDOSCOPY INC.5N2026-01-01204 Second Ave Waltham MA US 02451

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3513492005049571K243750SimpleStitch Suturing SystemOCW2025-04-17
3513491915062675K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)OCZ2024-12-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCW12025-04-17
OCZ12024-12-20

PMN#