510(k) clearances

FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

Apple Medical Corp. · Obstetrics/Gynecology

K061651Substantially EquivalentTraditionalHGI
Open FDA's page for this record
Third party flag
N
City
Marlboro
Advisory committee description
Obstetrics/Gynecology
Address 1
28 Lord Rd., Unit 135
Statement or summary
Summary
Product code
HGI
Zip code
01752
Applicant
Apple Medical Corp.
Decision date
2006-10-20
Decision code
SESE
Country code
US
Device name
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
Advisory committee
OB
Contact
JOHN C PULFORD
K number
K061651
State
MA
Date received
2006-06-13
Review advisory committee
OB
Postal code
01752
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrocautery, Gynecologic (And Accessories)
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.4120
Device class
2
Registration number
1060680, 3007421149, 3010202439, 9610612, 1422634, 3005646850, 3005350457, 2032112, 1720747, 8043396, 3004491689, 3004519921, 1527736, 3016245399, 3011050570, 1043214, 3010041511, 3013557562, 3006638824, 3032109, 1721686, 3010361165, 8040510, 3011137372, 1054811, 3009103001, 9613793, 1721676, 9710649, 2183715, 3011120183, 1061927, 2183744, 3011989923, 1643817, 1718873, 2916714, 3003790304, 3005075853, 1836161 +26 more
FEI number
3002806315, 3007421149, 3005646850, 3002681132, 3005350457, 1720747, 3001451571, 3004491689, 3003040625, 1527736, 3016245399, 1000514656, 3011050570, 1043214, 1000208624, 3010041511, 3013557562, 3006638824, 3000203000, 1721686, 3002750084, 3010361165, 2183715, 3009103001, 3006469671, 1721676, 3011120183, 3003076831, 3001592626, 2183744, 3011989923, 1643817, 1718873, 2916714, 3003565435, 3003790304, 1000114185, 3005075853, 3006509795, 1721194 +26 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.