510(k) K142525
- Device
- PK Lap Loop
- Applicant
- Olympus Winter & Ibe GmbH
- 510(k) number
- K142525
- Product code
- HIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-21
- Date received
- 2014-09-08
- Regulation
- 884.4150
- Classification name
- Coagulator-cutter, Endoscopic, Bipolar (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
- Graham A.L. Baillie
- Address
- Kuehnstrasse 61 Hamburg DE 22045 22045
FDA Registration Numbers#
- 3003687489
- 1412854
- 3013247477
- 3004215117
- 9610617
- 3010202439
- 9611102
- 2020550
- 9610773
- 1651252
- 3003724334
- 1836161
- 3002807310
- 3011050570
- 3014342096
- 3008132398
- 3007699067
- 3009420598
- 3027454635
- 2244478
- 3008693678
- 1418479
- 1421101
- 8030607
- 3010707607
- 9617070
- 3015972753
- 3003790304
Source Documents#
Other 510(k) Records For Product Code HIN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | Lina Medical Aps | 2013-07-24 |
| K122983 | KSEA BIPOLAR ELECTRODE | KARL STORZ Endoscopy-America, Inc. | 2013-06-26 |
| K122605 | PKS BILL | Gyrus Acmi, Inc. | 2012-12-05 |
| K113080 | TUBALGATOR | Mectra Labs, Inc. | 2012-06-29 |
| K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | ETHICON, Inc. | 2011-12-02 |
| K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | Gyrus Acmi, Inc. | 2011-09-01 |
| K990147 | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 | Richard Wolf Medical Instruments Corp. | 1999-04-16 |
| K971565 | BICOAG COAGULATING FORCEPS | Everest Medical Corp. | 1998-03-12 |
| K926517 | ELMED LBC 50-P | Elmed, Inc. | 1994-11-15 |
| K943776 | COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | 1994-11-03 |
| K911699 | STI TISSUE MANIPULATOR | Surgical Technologies, Inc. | 1991-06-13 |
| K871745 | MODEL 26021C BIPOLAR COAGULATOR | KARL STORZ Endoscopy-America, Inc. | 1987-07-10 |
| K790043 | TRACOR, CANNULA, BICEPTS BIPOLAR | Neomed Corp. | 1979-02-08 |
| K781109 | FORCEPS, ELECTROSURGICAL | Kli | 1978-09-14 |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Kli | 1978-07-17 |
Legacy Summary#
summary
FDA Review#
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