FDA Device Intelligence
Home › NOVO SURGICAL, INC. › Novo Surgical Inc.

Novo Surgical Inc.

NOVO SURGICAL, INC. · Model E95664-11 · UDI-DI 00842331163586

KBN Prescription
3
510(k) clearances
47
Adverse events
1
Recalls
212
Facilities

Description

zenith mcivor mouth gag, 5 3/4" (14.6 cm), complete set includes frame, guard & 3 blades (4551-11, 4551-12, 4551-13)

Recalls

DateFirmReason
2018-02-16Aesculap Implant Systems LLCThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.