Aesculap Manual Laparoscopic Instruments
FDA 510(k) K944467 · Aesculap, Inc.
510(k) numberK944467
Submission
- Device name
- Aesculap Manual Laparoscopic Instruments
- Applicant
- Aesculap, Inc.
South San Francisco, CA, US - Received
- September 9, 1994
- Decision date
- October 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
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| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
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Questions and answers
When was Aesculap Manual Laparoscopic Instruments cleared by the FDA?
Aesculap Manual Laparoscopic Instruments (K944467) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 24 days after the submission was received.
What is the product code of K944467?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.