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Novo Surgical Inc.

NOVO SURGICAL, INC. · Model G6163-46 · UDI-DI 00842331153440

KOA Prescription
10
510(k) clearances
37
Adverse events
6
Recalls
114
Facilities

Description

payr pylorus clamps, w/ out pins, jaw length 5 3/4" (147.0 mm), 13 3/4" (35.0 cm)

Recalls

DateFirmReason
2020-04-01Aesculap Implant Systems LLCEndoscopic graspers may become separated at the weld from handle to the shaft of the device.
2020-04-01Aesculap Implant Systems LLCEndoscopic graspers may become separated at the weld from handle to the shaft of the device.
2019-04-10Uromedica Inc.Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT i
2017-05-01Cook Inc.COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti
2017-05-01Cook Inc.COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti
2017-05-01Cook Inc.COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.