FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
K Number: K981889
·
Decision Jul 31, 1998
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
15
Review Days
63
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Basic Information
- Device Name
- WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
- K Number
- K981889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Worldwide Medical Technologies, LLC
- Date Received
- May 29, 1998
- Decision Date
- July 31, 1998
- Product Code
- FCG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCG), ordered by most recent decision date.
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EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
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Other Clearances by Worldwide Medical Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K062214 | BRACHYSCIENCES STRANDPORT | Mar 1, 2007 | Substantially Equivalent |
| K023179 | READI-STRAND, MODEL PSSTRAND | Jul 2, 2003 | Substantially Equivalent |
| K022705 | READI-STRAND, MODEL PSSTRAND | Jun 9, 2003 | Substantially Equivalent |
| K022389 | READI-LOAD SYSTEM, MODEL PSS 1820RL | May 6, 2003 | Substantially Equivalent |
| K020641 | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 | Oct 29, 2002 | Substantially Equivalent |
| K020337 | READI-STRAND; MODEL PSSTRAND | Jul 29, 2002 | Substantially Equivalent |
| K020867 | BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL | May 20, 2002 | Substantially Equivalent |
| K991344 | WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS | Nov 5, 1999 | Substantially Equivalent |
| K982097 | WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD | Jun 25, 1998 | Substantially Equivalent |
| K981470 | WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE | Jun 19, 1998 | Substantially Equivalent |