FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KARL STORZ Bipolar Resectoscopes with HF Cable
K Number: K221893
·
Decision Mar 17, 2023
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
23
Applicant Total
25
Review Days
261
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Basic Information
- Device Name
- KARL STORZ Bipolar Resectoscopes with HF Cable
- K Number
- K221893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoscopy America, Inc.
- Date Received
- June 29, 2022
- Decision Date
- March 17, 2023
- Product Code
- FJL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FJL | Resectoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FJL), ordered by most recent decision date.
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Other Clearances by Karl Storz Endoscopy America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240506 | KARL STORZ Holders | Oct 22, 2024 | Substantially Equivalent |
| K223885 | HOPKINS Telescopes | Sep 14, 2023 | Substantially Equivalent |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | Jun 23, 2023 | Substantially Equivalent |
| K221004 | HOPKINS Telescopes | Dec 20, 2022 | Substantially Equivalent |
| K222504 | H1 | Nov 10, 2022 | Substantially Equivalent |
| K213194 | HD Mediastinoscope | Jun 23, 2022 | Substantially Equivalent |
| K221174 | Telepack + | May 13, 2022 | Substantially Equivalent |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Sep 3, 2021 | Substantially Equivalent |
| K203198 | KARL STORZ Metal Sterilization Trays | Jul 6, 2021 | Substantially Equivalent |
| K202272 | HD Mediastinoscope | May 11, 2021 | Substantially Equivalent |