Peak Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Peak Surgical, Inc. makes
Peak Surgical, Inc. manufactures tissue dissection devices, including the PlasmaBlade Plus, PlasmaBlade 3.OS, and PlasmaBlade TNA for tonsil and adenoid procedures. Their portfolio also includes suction coagulators and associated generator units, such as the Pulsar and Pulsar II models, designed for surgical applications.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Peak Plasmablade Plus Tissue Dissection Device Ref K102709
Regimes: 510(k) Registry: 510(k)Peak Plasmablade 3.OS Tissue Dissection Device Ref K093695
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Peak Suction Coagulator Ref K103775
Regimes: 510(k) Registry: 510(k)Pulsar Generator, Model PS100-100, And Peak Plasmablade Tissue Dissection Device, Model PS200-040 Ref K073057
Regimes: 510(k) Registry: 510(k)Peak Pulsar Ii Generator Model PS100-102 Ref K102029
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Peak Surgical, Inc., initiated on 2009-05-19. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 19 May 2009 Z-1022-2011 Unclassified (pre-2012) Terminated A customer reported that a patient suffered a burn while using the device.
Full distribution text
- 19 May 2009 Z-1022-2011 Unclassified (pre-2012) Terminated A customer reported that a patient suffered a burn while using the device.
Frequently asked questions
How many devices does Peak Surgical, Inc. have in the registry?
The registry currently lists 7 devices for Peak Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Peak Surgical, Inc.'s devices?
Among its 7 most recently registered devices, Peak Surgical, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Peak Surgical, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Peak Surgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Peak Surgical, Inc.?
FDA recall records list 1 recall initiated by Peak Surgical, Inc., the most recent initiated on 19 May 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Peak Surgical, Inc. in the registry?
The most recently registered devices listed for Peak Surgical, Inc. include PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE, PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE, PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE and PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES.