Morris Anti-Splatter Device for Endoscopes
FDA 510(k) K884097 · Circon Acmi
510(k) numberK884097
Submission
- Device name
- Morris Anti-Splatter Device for Endoscopes
- Applicant
- Circon Acmi
Stamford, CT, US - Received
- September 28, 1988
- Decision date
- April 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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More from Alton (Shanghai) Medical Instruments Co., Ltd.
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| K013165 | USA Series LaparoscopesGCJ · Traditional | 01/18/2002SE |
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| K905706 | GYN-1500 Hysteroscopic InufflatorHIG · Traditional | 02/28/1991SE |
| K905705 | Lap 3501 High Flow InsufflatorHIF · Traditional | 02/28/1991SE |
| K884025 | Circon Acmi Bicap II Therapeutic System BC-200KNS · Traditional | 03/03/1989SE |
| K884254 | Circon Acmi Bicap III Therapeutic SystemKNS · Traditional | 01/11/1989SE |
| K884252 | Circon Acmi Bicap Hemorrhoid System BH-10 & BHP-20KNS · Traditional | 01/10/1989SE |
| K884306 | Bicap Ablating Forceps BAF-7KNS · Traditional | 01/05/1989SE |
| K883819 | Bullard Intubating Laryngoscope Lar-A & Lar-PCCW · Traditional | 10/17/1988SE |
Questions and answers
When was Morris Anti-Splatter Device for Endoscopes cleared by the FDA?
Morris Anti-Splatter Device for Endoscopes (K884097) received a 510(k) decision of Substantially Equivalent on April 17, 1989, 201 days after the submission was received.
What is the product code of K884097?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.