FDA Product Code
FDA Product Code HIN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4150
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014-11-21 | Traditional | PDF ↗ |
| K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | Lina Medical Aps | 2013-07-24 | Traditional | PDF ↗ |
| K122983 | KSEA BIPOLAR ELECTRODE | KARL STORZ Endoscopy-America, Inc. | 2013-06-26 | Traditional | PDF ↗ |
| K122605 | PKS BILL | Gyrus Acmi, Inc. | 2012-12-05 | Special | PDF ↗ |
| K113080 | TUBALGATOR | Mectra Labs, Inc. | 2012-06-29 | Traditional | PDF ↗ |
| K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | ETHICON, Inc. | 2011-12-02 | Traditional | PDF ↗ |
| K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | Gyrus Acmi, Inc. | 2011-09-01 | Traditional | PDF ↗ |
| K990147 | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 | Richard Wolf Medical Instruments Corp. | 1999-04-16 | Traditional | PDF ↗ |
| K971565 | BICOAG COAGULATING FORCEPS | Everest Medical Corp. | 1998-03-12 | Traditional | PDF ↗ |
| K926517 | ELMED LBC 50-P | Elmed, Inc. | 1994-11-15 | Traditional | PDF ↗ |
| K943776 | COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | 1994-11-03 | Traditional | PDF ↗ |
| K911699 | STI TISSUE MANIPULATOR | Surgical Technologies, Inc. | 1991-06-13 | Traditional | PDF ↗ |
| K871745 | MODEL 26021C BIPOLAR COAGULATOR | KARL STORZ Endoscopy-America, Inc. | 1987-07-10 | Traditional | PDF ↗ |
| K790043 | TRACOR, CANNULA, BICEPTS BIPOLAR | Neomed Corp. | 1979-02-08 | Traditional | PDF ↗ |
| K781109 | FORCEPS, ELECTROSURGICAL | Kli | 1978-09-14 | Traditional | PDF ↗ |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Kli | 1978-07-17 | Traditional | PDF ↗ |
Product code HIN · Class II · Obstetrics/Gynecology. Data: openFDA.