# Microline Surgical, Inc.

- Location (FDA's records): Beverly, MA
- FDA decisions: 8 (2012–2024): 8 510(k) clearances
- Product codes: GEI (6), KCT (2)
- 510(k) review time since 2016: median 147 days, against 138 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Microline Pentax, Inc.: 3 (https://510kreport.com/company/microline-pentax)
- Starion Instruments: 2 (https://510kreport.com/company/starion-instruments)
- C/T Med System, Ltd.: 1 (https://510kreport.com/company/c-t-med-system)
- Transenterix, Inc.: 1 (https://510kreport.com/company/transenterix)
- Symmetry Medical: 1 (https://510kreport.com/company/symmetry-medical)

## Firms that cite its devices most
- Taiwan Surgical Corporation: 2 (https://510kreport.com/company/taiwan-surgical)
- Agency For Medical Innovations GmbH: 1 (https://510kreport.com/company/agency-for-medical-innovations)
- Getsch+Hiller Medizintechnik GmbH: 1 (https://510kreport.com/company/getsch-hiller-medizintechnik)

## Its most-cited devices
- K160706: ReNew V Handpiece Laparoscopic Instruments (2016), cited by 2
- K201884: ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm (2020), cited by 2
- K213127: ReNew Disposable Scissor Tips (2022), cited by 1

## Recent decisions
- K234147: ReNew XR Handpiece, 25cm, with Reference Markings  (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings  (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) (Apr 23, 2024)
- K213127: ReNew Disposable Scissor Tips (Mar 2, 2022)
- K201884: ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm (Oct 21, 2020)
- K160706: ReNew V Handpiece Laparoscopic Instruments (Oct 19, 2016)
- K152745: ReNew Sterilization Trays (Catalog #3708 and #3709) (May 12, 2016)
- K152743: M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) (Feb 8, 2016)
- K124029: Microline Flexible Ligating Shears (Mar 27, 2013)
- K122086: Thermal Ligating Shears (Aug 23, 2012)

Source page: https://510kreport.com/company/microline-surgical