FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SNOWDEN-PENCER IRRIGATION PUMP
K Number: K920985
·
Decision Jun 9, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
10
Review Days
99
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Basic Information
- Device Name
- SNOWDEN-PENCER IRRIGATION PUMP
- K Number
- K920985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Snowden-Pencer
- Date Received
- March 2, 1992
- Decision Date
- June 9, 1992
- Product Code
- HEI
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HEI | Monitor, Heart-Valve Movement, Fetal, Ultrasonic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEI), ordered by most recent decision date.
DRG REACTION CHAMBER/SAFETY TIP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INNERVISION IRRIGATION PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Snowden-Pencer
| K Number | Device Name | ||
|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | Mar 12, 1996 | Substantially Equivalent |
| K930666 | REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY | May 19, 1994 | Substantially Equivalent |
| K930667 | REUSABLE LAPAROSCOPIC INSTRUMENTS | May 16, 1994 | Substantially Equivalent |
| K924148 | DIAMOND-SHARP(R) TROCARS | Feb 28, 1994 | Substantially Equivalent |
| K924149 | ENDO I/A PROBE | Jan 26, 1993 | Substantially Equivalent |
| K920986 | SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 | Jun 4, 1992 | Substantially Equivalent |
| K913979 | ENDO I/A Y SET | Nov 27, 1991 | Substantially Equivalent |
| K913835 | SNOWDEN-PENCER INSUFFLATOR TUBING SET | Nov 7, 1991 | Substantially Equivalent |
| K861372 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY | Jun 19, 1986 | Substantially Equivalent |