FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PK Lap Loop
K Number: K142525
·
Decision Nov 21, 2014
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
15
Applicant Total
43
Review Days
74
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PK Lap Loop
- K Number
- K142525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Winter & Ibe GmbH
- Date Received
- September 8, 2014
- Decision Date
- November 21, 2014
- Product Code
- HIN
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIN), ordered by most recent decision date.
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KSEA BIPOLAR ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PKS BILL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TUBALGATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Olympus Winter & Ibe GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | May 21, 2026 | Substantially Equivalent |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Sep 23, 2025 | Substantially Equivalent |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | Aug 18, 2023 | Substantially Equivalent |
| K221522 | HF-cables (resusable) | Jan 19, 2023 | Substantially Equivalent |
| K223183 | Light-Guide Cables | Jan 13, 2023 | Substantially Equivalent |
| K213207 | Sheath, Stopcock Accessory | Dec 22, 2021 | Substantially Equivalent |
| K203492 | Instrument tray, for semi-rigid ureteroscope | Sep 15, 2021 | Substantially Equivalent |
| K210651 | Resection Electrodes with HF cable | Aug 3, 2021 | Substantially Equivalent |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | May 17, 2021 | Substantially Equivalent |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Apr 28, 2021 | Substantially Equivalent |