Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
The Endoscopic Bipolar Coagulator-Cutter (and accessories) is a surgical instrument used in minimally invasive gynecological procedures to simultaneously cut and coagulate tissue using bipolar radiofrequency energy, reducing bleeding during operations. It is classified as FDA Class 2, indicating moderate risk; manufacturers must demonstrate substantial equivalence to a predicate device through a 510(k) premarket notification before marketing. The product code is HIN, regulated under 21 CFR 884.4150, within the Obstetrics/Gynecology medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited third-party reviewer.
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Basic Information
- Product Code
- HIN
- Device Class
- FDA class 2
- Regulation Number
- 884.4150
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142525 | PK Lap Loop | Nov 21, 2014 | Substantially Equivalent | Olympus Winter & Ibe GmbH |
| K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | Jul 24, 2013 | Substantially Equivalent | Lina Medical Aps |
| K122983 | KSEA BIPOLAR ELECTRODE | Jun 26, 2013 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K122605 | PKS BILL | Dec 05, 2012 | Substantially Equivalent | Gyrus Acmi, Inc. |
| K113080 | TUBALGATOR | Jun 29, 2012 | Substantially Equivalent | Mectra Labs, Inc. |
| K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | Dec 02, 2011 | Substantially Equivalent | ETHICON, Inc. |
| K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | Sep 01, 2011 | Substantially Equivalent | Gyrus Acmi, Inc. |
| K990147 | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 | Apr 16, 1999 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K971565 | BICOAG COAGULATING FORCEPS | Mar 12, 1998 | Substantially Equivalent | Everest Medical Corp. |
| K926517 | ELMED LBC 50-P | Nov 15, 1994 | Substantially Equivalent | Elmed, Inc. |
| K943776 | COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES | Nov 03, 1994 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K911699 | STI TISSUE MANIPULATOR | Jun 13, 1991 | Substantially Equivalent | Surgical Technologies, Inc. |
| K871745 | MODEL 26021C BIPOLAR COAGULATOR | Jul 10, 1987 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K790043 | TRACOR, CANNULA, BICEPTS BIPOLAR | Feb 08, 1979 | Substantially Equivalent | Neomed Corp. |
| K781109 | FORCEPS, ELECTROSURGICAL | Sep 14, 1978 | Substantially Equivalent | Kli |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Jul 17, 1978 | Substantially Equivalent | Kli |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.