FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE
K Number: K896205
·
Decision Mar 22, 1990
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
13
Applicant Total
38
Review Days
147
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Basic Information
- Device Name
- MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE
- K Number
- K896205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dexide, Inc.
- Date Received
- October 26, 1989
- Decision Date
- March 22, 1990
- Product Code
- GCI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCI | Laryngoscope, Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCI), ordered by most recent decision date.
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GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Dexide, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991814 | MULTACHOICE INSTRUMENTS | Jun 23, 1999 | Substantially Equivalent |
| K990379 | MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES | Mar 4, 1999 | Substantially Equivalent |
| K981940 | MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES | Sep 25, 1998 | Substantially Equivalent |
| K981941 | MULTAPORT CANNULA REDUCER AND ACCESSORIES | Jul 29, 1998 | Substantially Equivalent |
| K953611 | DEXIDE ENDO-LUBE KIT | Sep 15, 1995 | Substantially Equivalent |
| K944509 | DEXIDE INSUFFLATION TUBING WITH FILTER | Feb 7, 1995 | Substantially Equivalent |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Mar 23, 1993 | Unknown |
| K923845 | DEXIDE LAPAROSCOPIC ACCESSORIES | Nov 25, 1992 | Substantially Equivalent |
| K921709 | ENDOBAG, MODIFICATION | Jul 14, 1992 | Substantially Equivalent |
| K913762 | MONOSCOPY(TM) BRAND, ENDOBAG | Oct 28, 1991 | Substantially Equivalent |