510(k) K101458
- Device
- LINA XCISE MODEL MOR-1515
- Applicant
- LINA MEDICAL APS
- 510(k) number
- K101458
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-11
- Date received
- 2010-05-26
- Regulation
- 884.1720
- Classification name
- Laparoscope, Gynecologic (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WALT BRITTLE
- Address
- 1289 N Fordham Blvd. Suite A-128 Chapel Hill NC US 27517 27517
FDA Registration Numbers#
- 8043903
- 3012460907
- 3009380063
- 3013247477
- 3008693678
- 1526711
- 3011986317
- 3004491689
- 3008595179
- 2029275
- 3004111573
- 9680515
- 3006787036
- 1418479
- 1820334
- 2648623
- 1412854
- 8010877
- 3012322232
- 1836161
- 3020746799
- 2936485
- 3003724334
- 3004361445
- 9680721
- 3019783123
- 9610773
- 9614969
- 3002808148
- 9610595
- 3009420598
- 3009756153
- 8010510
- 2434839
- 8030607
- 2248148
- 3010202439
- 8043746
- 3033043422
- 9610612
- 3006897899
- 1424263
- 1219602
- 3008571754
- 1218882
- 3009134855
- 3015972753
- 3025482817
- 1643264
- 3014342096
- 3011050570
- 1483278
- 3009039068
- 2647580
- 9612501
- 8044057
- 1649518
- 9615001
- 8010298
- 2916714
- 2320762
- 1061124
- 3012494290
- 1058584
- 3012507533
- 3007156625
- 8010456
- 1320894
- 3014279513
- 3009763019
- 3014461810
- 1055236
- 1035968
- 9611612
- 3001556604
- 1221826
- 2027009
- 2020550
- 3015540957
- 3007789561
Source Documents#
Other 510(k) Records For Product Code HET #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | 2025-08-29 |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | 2022-12-12 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021-09-17 |
| K210104 | SurroundScope System | 270surgical , Ltd. | 2021-07-08 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | 2021-03-12 |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020-08-21 |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | 2019-11-01 |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019-08-29 |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | 2018-01-18 |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2017-11-28 |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | 2017-03-21 |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 |
Legacy Summary#
summary
FDA Review#
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