Product code HIN
- Device name
- Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4150
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014-11-21 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05708265016402 | LiNA Bipolar Loop™ | LiNA Medical AG | 2026-04-02 |
| 05708265016389 | LiNA Bipolar Loop™ | LiNA Medical AG | 2026-04-02 |
| 00198506089381 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-04-02 |
| B382SD80055210 | Surgical Direct | Surgical Direct, Inc. | 2026-02-12 |
| 00842180135475 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-09-29 |
| 00842180135437 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-09-29 |
| 00198506026027 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-05-22 |
| 00198506026034 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-03-11 |
| 00198506020841 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-03-05 |
| 00198506060731 | ELMED INCORPORATED | ELMED INCORPORATED | 2024-08-26 |
| 00842180147447 | ELMED | ELMED INCORPORATED | 2022-08-29 |
| 14042761086261 | Olympus | OLYMPUS Winter & Ibe GmbH | 2020-07-31 |
| 00817984010914 | Bipolar Forceps | MECTRA LABS, INC. | 2019-01-25 |
| 00817984010907 | Bipolar Forceps | MECTRA LABS, INC. | 2019-01-24 |
| 00842180109797 | ELMED | ELMED INCORPORATED | 2017-10-30 |
| 00842180109780 | ELMED | ELMED INCORPORATED | 2017-10-30 |
| 00842180109438 | ELMED | ELMED INCORPORATED | 2017-09-14 |
| 00821925039537 | Gyrus ACMI | Gyrus ACMI, LLC | 2017-05-11 |
| 00842180107519 | ELMED | ELMED INCORPORATED | 2017-03-30 |
| 00842180107298 | ELMED | ELMED INCORPORATED | 2017-02-10 |
| 00842180107199 | ELMED | ELMED INCORPORATED | 2017-01-17 |
| 10801334013981 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-12-05 |
| 10801334000738 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-09-24 |
| 10801334005474 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-09-23 |
| 10801334001230 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-09-23 |
| 10801334000110 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-09-23 |
| 10705031200517 | GYNECARE VERSAPOINT | Ethicon Inc. | 2016-09-16 |
| 05708265004607 | LiNA Bipolar Loop™ | Lina Medical ApS | 2016-09-15 |
| 05708265004621 | LiNA Bipolar Loop™ | Lina Medical ApS | 2016-09-15 |
| 05708265004645 | LiNA Bipolar Loop™ | Lina Medical ApS | 2016-09-15 |