Worldwide Medical Technologies Intracervical Block Needle, Model TBD
FDA 510(k) K982097 · Worldwide Medical Technologies, LLC
510(k) numberK982097
Submission
- Device name
- Worldwide Medical Technologies Intracervical Block Needle, Model TBD
- Applicant
- Worldwide Medical Technologies, LLC
Woodbury, CT, US - Received
- June 15, 1998
- Decision date
- June 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
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| K991344 | Worldwide Medical Technologies Seeding SpacersKXK · Traditional | 11/05/1999SE |
| K981889 | Worldwide Medical Technologies Introducer NeedleFCG · Traditional | 07/31/1998SE |
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Questions and answers
When was Worldwide Medical Technologies Intracervical Block Needle, Model TBD cleared by the FDA?
Worldwide Medical Technologies Intracervical Block Needle, Model TBD (K982097) received a 510(k) decision of Substantially Equivalent on June 25, 1998, 10 days after the submission was received.
What is the product code of K982097?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.