VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
FDA 510(k) clearance K111751 · decided 2011-12-02
Clearance details
- K-number
- K111751
- Device name
- VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-22
- Decision date
- 2011-12-02
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- HIN
- Device class
- 2
- Regulation number
- 884.4150
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| PK Lap Loop (K142525) | Olympus Winter & Ibe GmbH | 2014-11-21 |
| LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (K130305) | Lina Medical Aps | 2013-07-24 |
| KSEA BIPOLAR ELECTRODE (K122983) | KARL STORZ Endoscopy-America, Inc. | 2013-06-26 |
| PKS BILL (K122605) | Gyrus Acmi, Inc. | 2012-12-05 |
| TUBALGATOR (K113080) | Mectra Labs, Inc. | 2012-06-29 |
| GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (K111059) | Gyrus Acmi, Inc. | 2011-09-01 |
| BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 (K990147) | Richard Wolf Medical Instruments Corp. | 1999-04-16 |
| BICOAG COAGULATING FORCEPS (K971565) | Everest Medical Corp. | 1998-03-12 |
| ELMED LBC 50-P (K926517) | Elmed, Inc. | 1994-11-15 |
| COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (K943776) | Richard Wolf Medical Instruments Corp. | 1994-11-03 |
| STI TISSUE MANIPULATOR (K911699) | Surgical Technologies, Inc. | 1991-06-13 |
| MODEL 26021C BIPOLAR COAGULATOR (K871745) | KARL STORZ Endoscopy-America, Inc. | 1987-07-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |