Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
- 510(k)K201150Substantially equivalent (SESE) · 2020-07-22clearance family
- 510(k)K200947Substantially equivalent (SESE) · 2020-07-02clearance family
- 510(k)K192695Substantially equivalent (SESE) · 2019-12-27clearance family
Predicate lineage
- K192695
- K200947
Cited as predicate by: K210492
Cited as predicate by: K212253, K221571, K231790, K242598, K252367
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- Arm Monopolar scissors DEX SURGICAL
- Arm Needle holder DEX SURGICAL
- Control Handle Left DEX SURGICAL
- Control Unit DEX SURGICAL
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR SONTEC INSTRUMENTS, INC.
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR SONTEC INSTRUMENTS, INC.
- DR. BEALE-LAP CHOLE KIT APPLIED MEDICAL RESOURCES CORPORATION
- DR. BEHR'S LAP CHOLE APPLIED MEDICAL RESOURCES CORPORATION
- DR. TENEWITZ APPLIED MEDICAL RESOURCES CORPORATION
- DR. TENEWITZ / DR. FASWASZ APPLIED MEDICAL RESOURCES CORPORATION
- Electrode LIPO Chungwoo Co., Ltd.
- J Hook for Bovie Pencil Handle ORANGE SURGICAL INSTRUMENTS, LLC