FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AESCULAP THORACOSCOPIC INSTRUMENTS
K Number: K944955
·
Decision Nov 9, 1994
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
207
Review Days
33
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
- AESCULAP THORACOSCOPIC INSTRUMENTS
- K Number
- K944955
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- October 7, 1994
- Decision Date
- November 9, 1994
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.
Sphincterotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vanquish Water Vapor Ablation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SureTome SW Sphincterotome with DomeTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Aesculap, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | May 13, 2025 | Substantially Equivalent |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Dec 16, 2024 | Substantially Equivalent |
| K223596 | SQ.line KERRISON | Jun 29, 2023 | Substantially Equivalent |
| K214041 | Aesculap AICON Container | Dec 30, 2022 | Substantially Equivalent |
| K211572 | Aesculap Slim Clip Applier | Dec 13, 2021 | Substantially Equivalent |
| K203739 | ELAN 4 Electro Motor System | Aug 24, 2021 | Substantially Equivalent |
| K202391 | DIR 800 | Jan 21, 2021 | Substantially Equivalent |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Dec 18, 2020 | Substantially Equivalent |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Oct 30, 2020 | Substantially Equivalent |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Sep 2, 2020 | Substantially Equivalent |