Incisive Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Incisive Surgical, Inc. makes
Incisive Surgical, Inc. makes absorbable staples, including the INSORB Absorbable Staple and various models such as SP-B20 and 1020.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.
Catalogue
Insorb Absorbalbe Staple Ref K120373
Regimes: 510(k) Registry: 510(k)Insorb Absorbable Staple, Model Sp-B20 Ref K033602
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Insorb Absorbable Staples, Model Sp-B20 Ref K024117
Regimes: 510(k) Registry: 510(k)Insorb Absorbable Staple, Model 1020 Ref K061784
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Incisive Surgical, Inc., the earliest on 2015-03-19 and the most recent on 2018-08-29. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 29 Aug 2018 Z-0078-2019 Class II Terminated Possible compromise of the sterile barrier integrity
2015
- 19 Mar 2015 Z-1545-2015 Class II Terminated A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.
Frequently asked questions
How many devices does Incisive Surgical, Inc. have in the registry?
The registry currently lists 5 devices for Incisive Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Incisive Surgical, Inc.'s devices?
Among its 5 most recently registered devices, Incisive Surgical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Incisive Surgical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Incisive Surgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Incisive Surgical, Inc.?
FDA recall records list 2 recalls initiated by Incisive Surgical, Inc., the most recent initiated on 29 Aug 2018. 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 Incisive Surgical, Inc. in the registry?
The most recently registered devices listed for Incisive Surgical, Inc. include INSORB ABSORBALBE STAPLE, INSORB ABSORBABLE STAPLE, MODEL SP-B20, INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES and INSORB ABSORBABLE STAPLES, MODEL SP-B20.